Job Title: Regulatory Affairs Manager I
Career Level - D
Introduction to Role:
Are you ready to take on a role that lets you flex your regulatory expertise and project management skills? As a Regulatory Affairs Manager I at AstraZeneca, you'll be a key player in our Global Regulatory Execution Team (GRET), taking on responsibilities in Regulatory Affairs Management, Global Labelling Management, and Dossier Management. You'll be working in a dynamic environment, leading cross-functional activities and contributing to the continuous improvement of our processes and tools.
Accountabilities:
In this role, you'll be responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. This includes contributing to regulatory submission strategy, identifying submission risks and opportunities, and managing procedures through approval. You'll also provide regulatory expertise and mentorship on procedural and documentation requirements to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams.
Essential Skills/Experience:
Relevant University Degree in Science or related field
Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry
Detailed knowledge of the regulatory product maintenance process
Strong project management skills
Leadership skills, including experience leading multi-disciplinary project teams.
Desirable Skills/Experience:
Regulatory affairs experience across a broad range of markets
Led regulatory results at the project level
Experience of working with people from locations outside of India, especially Europe and/or USA
Excellent English written and verbal communication skills
Cultural awareness
Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
Proficiency with common project management (e.g., MS Project) and document management tools
Ability to work independently and as part of a team
Influencing and stakeholder leadership skills
Ability to analyze problems and recommend actions
Continuous Improvement and knowledge sharing focused.
When we put unexpected teams in the same room, we unleash aggressive thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
At AstraZeneca, we're all about innovation. We're constantly pushing beyond traditional boundaries in the field of biopharmaceuticals, turning our drug development strategies into reality. We're not just about spotting risks - we're solution-oriented, using our capabilities to accelerate discovery and development. We're part of the solution, involved in key discussions, acting as both a drug developer and regulator. We're committed to finding improvements that will impact patients with serious diseases. We're championing a new mindset for Regulatory - shifting from conservative to progressive. Here at AstraZeneca, you'll get the opportunity to work on projects at all stages of development. We're working towards making AstraZeneca the place to build a career in Regulatory.
Ready to innovate in a safe environment? Join our team with deep specialist knowledge and Regulatory expertise. Apply now and be part of our journey to push the boundaries of science and make a difference!
Date Posted
Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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